Consultation Services

 

Teco Diagnostics is committed to advancing clinical diagnostic practices. Teco helps our clients by providing in-vitro chemical diagnostic tests and instruments. By working together and using industry standardized Regulatory Affairs, Clinical Affairs and Quality Assurance, Teco and our clients can successfully bring new and innovative products to market.

 

We have successfully prepared and submitted FDA 510(k) submission for medical device and clinical diagnostic products.  Teco Diagnostics can assist with research and development projects and the following aspects of the 510(k) clearance process:

  • pre-market assessment
  • protocol reviews
  • statistical strategies
  • regulatory applications
  • 510(k) and PMA support
  • investigational site monitoring
  • data entry
  • statistical analysis
  • data management
  • final reports
  • investigational site audits
  • sponsor audits
  • medical device clinical research training in good clinical practices (GCP)
  • clinical study design
  • project management for clinical studies

 

Teco Diagnostics strives for efficient and effective solutions when assisting clients in developing, manufacturing, and commercializing diagnostic assays. We can design, develop, integrate, and validate each new product within regulatory compliance guidelines. Teco Diagnostics staff members have a vast knowledge of science, regulatory affairs, and product development. This enables us to coordinate and execute product development and clearance for in-vitro diagnostic (IVD) products and new medical devices.

 

Primary Services:

  • Contract assay development
  • Contract diagnostic manfacturing
  • Sales of supporting products, including assay materials, controls, and critical reagents

 

Compliant with:

  • College of American Pathologists (CAP) Accreditation Consulting
  • Good Laboratory Practice (GLP) consulting
  • ISO 13485
  • Current Good Manufacturing Practices (cGMP)
  • CE Market Regulations

 

If you are interested in our consultation services, please contact stephen [at] tecodiagnostics.com for more information.